The present invention relates to a method for determining a volume related to the lungs of a patient.

The present invention also relates to a device for determining a volume related to the lungs of a patient.

The lungs are a dynamic organ, which during a breath change volume by the respiratory gas streaming into alveoli (inhalation, inspiration) as well as out of the alveoli (exhalation, expiration). To characterize the different volumes, a number of parameters are accepted. Some of these are: tidal volume, which is a measure of the volume inhaled/exhaled during a normal breath; vital capacity, which is the total volume for a maximal inhalation and a maximal exhalation; functional residual capacity (FRC), which is a measure of the volume remaining in the lungs after a normal exhalation; and ineffective tidal volume, which is a measure of the gas volume which does not contribute to the gas exchange between the lungs and blood circulation during a breath (constituted mainly by the volume in the bronchial branches and the wind-pipe).

In EP 0 653 183, a method and an apparatus useful for determining the functional residual capacity, FRC, is described. One example of the method principally operates in that during a washing-in phase, an inert and non-toxic labelled gas is applied with the respiratory gas during inspiration until an equilibrium in the concentration of labelled gas is obtained in the lungs. The supply is stopped, and by measuring the stream and concentration of labelled gas during a succession of expiration (washing-out phase), the exhaled volume of labelled gas can be determined, which (taking into consideration the dead volumes in the apparatus and the patient) constitutes FRC.

The known method functions well: but obviously requires some special equipment for functioning as required in a clinical environment. To provide all the ventilators, narcotic apparatuses, etc. with complete equipment for supply of a suitable labelled gas and measure the concentration of the same is not economically motivatable, particularly not if the measuring equipment should be able to measure a series of possible labelled gases.

Another factor is that the labelled gases which are to be used clinically must be approved for this use and eventually handled in a special way. Certain gases, such as SF₆, are themselves very suitable but result at the same time in requirements on how the gas is handled, even if they were approved for normal clinical use in a hospital. SF₆ is for example even a greenhouse gas, and unnecessary release in the atmosphere must be minimized.

There is therefore desirable to provide a method and a device for simple and certain determining of volumes related to the lungs of a patient, particularly FRC.

There is also a desire to provide a method and a device for determining volumes related to the lungs of a patient, particularly FRC, which can be applied directly in a clinical environment without lengthy complications in the existing apparatuses for dosing, measuring or taking into custody specific labelled gases.

The invention is defined in the claims. Other embodiments are presented for illustrative purposes only.

The invention is based on the understanding that a change of the inspirational gas composition results in a variable change in the expirational gas composition (until an equilibrium is reached). By determining these variations in a measurement parameter the volume can be determined.

In an advantageous development of the method, an ultrasound flow meter is used to perform the determination.

Flow determination with ultrasound is a known method, even used in medical ventilators (e.g. Servoⁱ, Maquet Critical Care AB, Solna, Sweden). By sending a sound pulse downstream in the flow stream and a sound pulse upstream in the flow stream, a flow speed can be determined (from the difference in duration between downstream and upstream). A non-flow dependent time-of-flight (duration for the sound signal) can be obtained by determining the average for the duration times for upstream and downstream.

The acoustical properties for gases depend among other things on the composition of the gas, e.g. the proportion of oxygen in the respiratory gas. This is used in the present invention. By introducing a change in the composition of the respiratory gas for one or more inspirations, the composition of the expired gas successfully changes until an equilibrium state is reached in the lungs. By determining how the successively changed expiration gas affects the sound pulses, a volume determination can be made.

A parameter suitable to use is the non-flow dependent duration (time-of-flight). Since the composition of the gas successively changes during a series of expirations, even the non-flow dependent duration will vary. By determining the time constant for this variation, a volume for the lungs can be determined.

In a modification of this, a fictitious time t' can be used. This is to reduce the influence of variations in the depth of breath and breathing intervals during the measurement of spontaneously-breathing patients. That is because the change in gas composition first is a volume-dependent process and not time-dependent. The fictitious time t' is therefore determined in relation to the total passing stream volume and a taken constant flow.

Alternative examples for use of the ultrasound flow measurer include, for example, determining the variation in gas composition with a gas concentration measurer or with a heat radiation measurer (the variation in gas composition affects the conductivity of heat).

The change in gas composition which is supplied to the breathing gas can consist of a step change, where the change exists during the entire measuring procedure.

Alternatively the change can be performed pulsed, where a large change occurs for one or a few breaths. After that, one returns to the normal gas composition. This results in a lower effect on the patient during the entire measuring procedure.

The change can result in a variation of the oxygen content which, for example, in a step change could result in an increase with 5% oxygen content from a usual level of 30-35%. A pulsed change could constitute an increase from e.g. 21% to 100% for two breaths.

It is evident that even other changes of the gas composition are possible. The changes can relate to some other gas component than oxygen, e.g. laughing gas or xenon (anaesthetic). The change can occur by supplying a specific disturbance gas (as from the state of the technique), e.g. helium. The large advantage compared with the state of technique is that the actual composition of the gas in reality is irrelevant; it is the variation in a measuring parameter which is important

To minimize disturbances in the measurements, particularly disturbances which relate to variations in temperature, humidity, etc. (which also can influence the speed of sound), it is suitable to take all measurement data from correlated time points in each expiration, e.g. in the final phase of the expiration.

A device which at least fills some of the goals is achieved in accordance with the invention through the device according to the preamble to claim 11 formed as given in the characterizing part of claim 11.

Advantageous further developments and designs of the device are evident from the claims dependent on claim 11.

Principally the device is formed to be able to perform the method described above.

The device can be formed in many different ways and with many complexities. The device can in this connection constitute a handheld tube with a measurement chamber and an ultrasound unit and a mouthpiece for inserting interference in the gas composition. The latter can constitute a capsule filled with compressed gas, e.g. oxygen or helium, which is released during one or a few breaths, after which the variation in the parameter is measured and the volume is determined according to the above.

Alternatively, the device can constitute a ventilator formed to execute the method.

The invention will be described in more detail in connection with the figures.

• Fig. 1 shows a first example of a device,
• Fig. 2 shows a first model of a lung,
• Fig. 3 shows in a diagram a first measurement series when determining a volume,
• Fig. 4 shows in a diagram a second measurement series when determining a volume,
• Fig. 5 shows in a diagram how variable breathing volume and variable breathing interval can affect the determination,
• Fig. 6 shows a second model of a lung,
• Fig. 7 shows in a diagram how compensating can be done for variable breathing volume and variable breathing interval, and
• Fig. 8 shows a second example of a device.

Fig. 1 shows a hand held test apparatus 2 as a first example of the device. The test apparatus 2 comprises in principle a tube 4 provided with a mouthpiece 6 for a patient to breathe in and out through. In that regard the tube 4 constitutes an inspiration part as well as an expiration part for the test apparatus 2.

It should be noted that "patient" has a wide scope which comprises all people and lung-breathing animals for which a volume related to the lungs according to the method described below can be determined.

To determine a volume related to the lungs of a patient, a disturbance must be introduced in the composition of the breathing gas. For the test apparatus 2 the breathing gas consists of regular air. A gas capsule 8 can be connected to the tube to supply a gas which changes the composition of the breathing gas.

The gas capsule 8 can preferably contain a compressed gas to minimize its volume and simplify dosing. The gas can constitute oxygen, helium or some other non-toxic gas for which the speed of sound deviates from the speed of sound in the respiratory gas.

The gas in the gas capsule 8 can be released during one or a few breaths. The release can be done by simple ventilation, fixed flow opening, breaking of a membrane, etc., depending on whether the composition shall be changed during a few or more breaths.

In the tube 4 there is also a first transceiver 10 and a second transceiver 12 arranged to determine a non-flow dependent duration (time-of-flight) for sound pulses in expired gas (mean value of upstream duration and downstream duration, respectively). In this connection the tube 4 constitutes a measuring chamber for the determination. The transceivers 10, 12 can in principle also be replaced with a sound sender and a sound receiver for determining the duration upstream and a second pair of sound sender and sound receiver for determining the duration downstream. Alternatively, a transceiver can be used in one end of the measuring section and a sound reflector in the other. Other arrangements of components can obviously also be used for determining the duration of one or more sound pulses, e.g. by determining the duration perpendicularly to the flow.

The determination of the duration is done during a couple of breaths, during which the gas composition in the lungs returns to normal.

In a calculation unit 14 the actual calculation is made of the volume which is to be determined. The calculation unit 14 can be integrated with the test apparatus 2 as shown in the figure but can also constitute a separate component, which communicates with the test apparatus via cable or wireless.

In Fig. 2 a model of a lung is shown from which a calculation model can be described. The lungs correspond to this model of a container 16 with the volume V. The volume V is ventilated with an alveolar flow V_A. Assuming a good blend in the volume V, the following equation for a change in the oxygen concentration is obtained: $$\bar{\mathrm{V}}\cdot {\mathrm{dF}}_{{\mathrm{O}}_{\mathrm{2}}}=\left({\dot{\mathrm{V}}}_{\mathrm{A}}\cdot {\mathrm{F}}_{\mathrm{mix}}-{\dot{\mathrm{V}}}_{\mathrm{A}}\cdot {\mathrm{F}}_{{\mathrm{O}}_{\mathrm{2}}}\right)$$
where V constitutes the mean volume. This has the differential equation: $$\frac{{\mathrm{dF}}_{{\mathrm{O}}_{\mathrm{2}}}}{\mathrm{dt}}=\frac{{\dot{\mathrm{V}}}_{\mathrm{A}}\cdot {\mathrm{F}}_{\mathrm{mix}}-{\dot{\mathrm{V}}}_{\mathrm{A}}\cdot {\mathrm{F}}_{{\mathrm{O}}_{\mathrm{2}}}\left(\mathrm{t}\right)}{\bar{\mathrm{V}}}$$
which has the solution: $${\mathrm{F}}_{{\mathrm{O}}_{\mathrm{2}}}\left(\mathrm{t}\right)=\frac{{\dot{\mathrm{V}}}_{\mathrm{A}}\cdot {\mathrm{F}}_{\mathrm{mix}}}{{\dot{\mathrm{V}}}_{\mathrm{A}}}+\left[{\mathrm{F}}_{{\mathrm{O}}_{\mathrm{2}}}^{\mathrm{start}}-\frac{{\dot{\mathrm{V}}}_{\mathrm{A}}\cdot {\mathrm{F}}_{\mathrm{mix}}}{{\dot{\mathrm{V}}}_{\mathrm{A}}}\right]\cdot {\mathrm{e}}^{-\frac{{\dot{\mathrm{V}}}_{\mathrm{A}}}{\bar{\mathrm{V}}}\mathrm{t}}$$

Knowing the time constant τ, the mean volume V can be calculated through: $$\bar{\mathrm{V}}=\mathrm{\tau }\cdot {\dot{\mathrm{V}}}_{\mathrm{A}}=\mathrm{\tau }\cdot \left({\dot{\mathrm{V}}}_{\mathrm{E}}-{\dot{\mathrm{V}}}_{\mathrm{D}}\right)$$
where V_E represents expired minute volume and V_D represents dead volume ventilation. From the mean volume, for example FRC can be determined by subtracting the volume corresponding among others to the dead volume.

The time constant τ can be determined from the change in duration time for the sound pulses through the breathing gas.

Fig. 3 shows a measuring series 18 of the duration time for a number of breathing cycles. The duration time varies during the entire breathing cycle, but at breathing cycle 20 a step change is initiated in the breathing gas composition and a lapse curve starts. From a first series of measuring points 22 the time constant τ for the lapse curve can be determined.

The measuring points 22 are correlated to one and the same time point during the respective breathing cycle, i.e. they are taken during practically identical circumstances regarding temperature, humidity, CO₂, etc. In that way the measuring points 22 are, as much as possible, independent of all factors which can affect the duration time. In principle, the maximum and/or minimum values could also be used to determine the time constant τ.

At the breathing cycle 24 the gas composition is restored to the original. A second series of measuring points 26 can in this connection be used to execute the same determination once again. The two measurements executed in this way can be used to control that the determined volume is appropriate.

If oxygen is used as changing gas in connection with a step change as described above, an undesired effect in the form of modified gas exchange in the lungs can affect the result. To minimize such an effect, a pulsed change of the gas composition can instead be made.

Fig. 4 shows a measurement series 28 where a pulsed change of the gas composition has been made in breathing cycle 30. The pulsed change constitutes in this case pure oxygen, which is supplied to the patient during two breathing cycles. Subsequently the time constant τ is determined from a series of measurement points 32 in the same way as described above.

The pulse method results in a shorter time with deviating gas composition in the lungs. The pulse method even increases the accuracy in the determination since factors such as physical solubility in blood and metabolistic changes are minimized.

Fig. 2 shows a model to represent the lungs and the ventilation of them. A drawback with the model in Fig. 2 is that it presumes a relatively constant breathing rhythm, i.e. the breathing volume and the breathing interval are constant for each breathing cycle.

Fig. 5 illustrates the effects of a variation in breathing volume and interval for the model according to Fig. 2. An upper graph shows the oxygen change over time, corresponding to the washing-in duration with a changed oxygen concentration. A lower graph shows the tidal volume over time for four breaths 34A, 34B, 34C, 34D. The exponential function 36 in the upper graph shows an ideal change at the washing-in (to determine the time constant τ). The curve 38 shows the actual changes during the four breathing cycles 34A, 34B, 34C, 34D. The actual change of the oxygen concentration depends on the breathing volume. The first breath 34A accordingly results in a first step change 40A in the oxygen concentration. The second breath 34B, which has a considerably lower tidal volume, only results in a small second step change 40B. The third breath 34C occurs after a long pause and also has a low tidal volume. A third step change 40C is therefore also low and occurs after a corresponding time interval. The fourth breath 34D finally occurs short after the third breath 34C and has a larger tidal volume. The corresponding fourth step change 40D will in this connection also be larger and reaches up to the exponential function 36. The washing-in is then done.

It is clear that it is difficult to adapt the curve 38 to the exponential function 36.

To more easily be able to determine the exponential function and the time constant at the volume determination, instead a model according to Fig. 6 could be used. In this model the lungs again correspond to a container 42. The container has a volume V through which a constant flow V_in = V_ut = V streams. This means that the washing-in or washing-out duration can be described as follows: $${\mathrm{F}}_{{\mathrm{O}}_{\mathrm{2}}}\left(\mathrm{t}\right)={\mathrm{F}}_{\mathrm{in}}+\left({\mathrm{F}}_{{\mathrm{O}}_{\mathrm{2}}}\left(\mathrm{0}\right)-{\mathrm{F}}_{\mathrm{in}}\right)\cdot {\mathrm{e}}^{-\frac{\mathrm{V}}{\bar{\mathrm{v}}}\mathrm{t}}$$

By supposing a constant flow, f, and determining the total volume of gas, V_tot, which is washed through the lungs, a fictitious time, t', can be determined accordingly: $$\mathrm{tʹ}\left(\mathrm{n}\right)=\frac{{\displaystyle \sum _{\mathrm{i}=\mathrm{0}}^{\mathrm{n}}}{\mathrm{V}}_{\mathrm{i}}}{\mathrm{f}}$$

The variable fictitious time, t', is going to correspond to the time which had passed if a continuous flow had passed the lungs, i.e. more like the situation which is present at a regular breathing rhythm.

In Fig. 7 upper and lower graphs corresponding to those in Fig. 5 are shown. The lower graph shows the four breaths 34A, 34B, 34C and 34D. The upper graph shows the exponential function 34. The curve 44 shows how the fictitious time t' results in a better adaptation than the curve 38 in Fig. 5. The first breath 34A which occurs at time point t₁ corresponds in the fictitious number scheme to a first step change 46A at time point t'₁. The second breath 34B at time point t₂ had a lesser tidal volume. This corresponds to a second smaller step change 46B at time point t'₂. The third breath 34C at time point t₃ corresponds in the same way to a third step change 46C at time point t'₃, and the fourth breath 34D at time point t₄ corresponds to a fourth step change 46D at time point t'₄.

It is clearly evident that the curve 44 better corresponds to the exponential function 36 than the curve 36 in Fig. 5.

Fig. 8 shows a second embodiment of a device. In this case the device constitutes a ventilator 48 which is connectable to a patient 50 via a hose system 52. The ventilator 48 can, for example, be a modified Servoⁱ, Maquet Critical Care AB, Solna, Sweden.

The ventilator 48 comprises an inspiration part 54, an expiration part 56, a calculation unit 58 and a user interface 60. In the following all components which can be used in a ventilator are not taken up, but only those which are of significance to perform volume determinations according to the above described processes. A large number of other components are known and could consequently be included in the ventilator 48.

The inspiration part 54 in itself consequently comprises, among other things, connections 62A, 62B for gases, e.g. air and oxygen, and a gas regulator 64, which regulates the composition, pressure and flow of the breathing gas. The expiration part 56 comprises a flow meter 66, which measures flow with ultrasound. The calculation unit 58 can comprise one or more processors or the like and can include all controlling and watching functions for the ventilator 48. The user interface 60 can comprise an interactive screen 68 for introduction of breathing modes, initiating the process, etc., and can show measurement data, curves and calculated volumes.

An example of how a volume-determination function for determining FRC can be implemented in the ventilator 48 is that a measurement is initiated by requesting a volume determination via the user interface 60. The calculation unit 58 then controls the gas regulator 64 so that a change in the breathing gas composition is initiated, e.g. in the form of two breaths with 100% oxygen.

In the flow meter the duration time is determined for the sound pulses which are used to determine the flow. From the flow is even received the volume of gas passing out. Out of the duration time measurement, which in principle can be similar to the measurement shown in Fig. 4, measuring points are taken from the same phase in the breathing cycle for a number of breathing cycles. From the measuring points the time constant τ and the mean volume in the lungs are determined. To obtain FRC the dead volume is subtracted (which can be determined in a known manner).

Even if only the ultrasound measurer is explicitly described in the embodiments of Fig. 1 and Fig. 8, respectively, other components could be used in a corresponding way to take the time constant (or corresponding parameter) to perform the volume determination. Gas detectors and heat radiating detectors have been mentioned earlier. Use of these results in equivalent equations and connections between volume and time constant.